Wearable injector with sterility sensors

ABSTRACT

An on-body drug delivery device having a housing and a cartridge removably attachable to the housing. The cartridge comprises: a drug chamber, a piston received in the drug chamber movable from a first, initial position to a second position, an actuation device for moving the piston from the first position to the second position, and at least one breakable sterility sensor circuit formed by attachment of the cartridge to the housing, the circuit being closed when the cartridge is properly attached to the housing and broken if the cartridge is not properly attached to the housing or removed from the housing after being attached thereto, and/or the circuit being broken if the piston is not in the initial position when the cartridge is first attached to the housing.

BACKGROUND Field of the Disclosure

The present disclosure relates to drug delivery/infusion devices. Moreparticularly, the present disclosure relates to devices mounted to thebody for automatically delivering a drug to a patient.

Description of Related Art

Delivery of liquid drugs to a patient via injection using a needle orsyringe is well-known. More recently, devices that automate the deliveryof liquid drugs have been introduced. These devices (which are commonlyreferred to as “on-body devices” or “on-body injectors”) are mounted orotherwise secured to the body of the patient (e.g., to the arm orabdomen) and remain in place for an extended amount of time (on theorder of hours or days), injecting an amount of the drug into the bodyof the patient at one or more scheduled times. For example, a device maybe configured to deliver a drug over the span of 45 minutes, withdelivery beginning 27 hours after the device has been activated andapplied to a patient (to ensure that the drug is not delivered soonerthan 24 hours after a medical procedure or treatment). These devicesimprove upon manual methods by obviating the need for the patient toinject themselves with the drug (which carries heightened risks of thepatient improperly administering the injection or injecting the drug atan inappropriate time) or to return to a medical facility for one ormore injections by a technician or medical professional.

One known on-body device 10 is shown in FIGS. 1 and 2 . The device 10 ofFIG. 1 includes a housing 12 that contains or encloses the functionalcomponents of the device 10, which are shown in FIGS. 3 and 4 .

The internal components of the device 10 include a reservoir 14 that isconfigured to be filled with a liquid drug to be delivered to thepatient. An upper surface of the housing 12 includes a fill indicator 16that provides a visual indication of the amount of fluid in thereservoir 14. In addition to the fill indicator 16, the upper surface ofthe housing 12 may include printed information, such as informationregarding the drug to be delivered. The upper surface of the housing 12may be formed of a translucent material, which allows light from astatus light 18 (which may be configured as a light-emitting diode)mounted within the housing 12 (FIG. 1 ) to be seen through the uppersurface of the housing 12. The status light 18 is electrically coupledto a controller or processor (which may be a CPU or MPU configured as acomputer chip mounted to a printed circuit board positioned within thehousing 12, for example) that carries software for executing a drugdelivery routine. The status light 18 receives signals from thecontroller and emits light to provide information regarding a status ofthe device 10. This may include emitting differently colored lightand/or emitting light in different flashing patterns to indicatedifferent conditions, such as a blinking orange light to indicate thatthe device 10 is ready to be applied to a patient, a blinking greenlight to indicate proper operation of the device 10, and a blinking redlight to indicate an error or other condition. One or more batteries 20provide power to the status light 18 and the other electrical componentsof the device 10.

The drug is injected into the reservoir 14 using a (typicallypre-filled) syringe 22 via a port 24 incorporated into the bottom orunderside of the housing 12 (FIG. 4 ) and fluidically connected to thereservoir 14. FIGS. 1 and 2 illustrate an applicator 26 that isremovably associated with the underside of the housing 12 and used incombination with the syringe 22 to fill the reservoir 14 via the port24. The drug is most typically injected into the reservoir 14 by amedical professional immediately before the device 10 is secured to thepatient to ensure that the proper drug is supplied, along with theproper amount.

A piston or plunger 28 (FIG. 4 ) positioned within the reservoir 14 ismoved (from left to right, in the orientation of FIG. 4 ) as the spacewithin the reservoir 14 is filled by the inflowing drug. Movement of thepiston 28 into its final position (when the reservoir 14 has been filledwith the appropriate amount of the drug) causes a portion of a rodassociated with the piston 28 to extend from the reservoir 14 to createan electrical connection, which activates the device 10. Activation ofthe device 10 may include a signal, such as a buzzer providing anaudible indication that the device 10 has been activated and/or a lightemitted by the status light 18.

When the device 10 has been activated, it is mounted or secured to thebody of the patient. The applicator 26 is first removed from theunderside of the housing 12 and discarded, followed by a pull tab 30being manipulated to remove a release film from an adhesive pad 32associated with the underside of the housing 12. The housing 12 is thenpressed against the body of the patient, with the adhesive pad 32 facingthe body. An adhesive present on the adhesive pad 32 causes the adhesivepad 32 (and, hence, the housing 12) to adhere to the body.

Some predetermined time after the device 10 has been activated (whichmay be on the order of three to five minutes, for example), a distal endportion of a cannula 34 is introduced into the skin of the patient via acannula window 36 defined in the housing 12 (FIGS. 3 and 4 ). Thecannula 34 (which remains partially positioned within the skin of thepatient for as long as the device 10 is in use) is formed of a flexibleor semi-rigid material, such as a plastic material, for improved patientcomfort.

As the cannula 34 is not itself configured to pierce the skin, anassociated needle 38 is provided within the lumen of the cannula 34,with a sharp or beveled distal end of the needle 38 extending out of adistal end of the cannula 34. A midsection of the needle 38 is mountedwithin a needle carriage 40, while a proximal end 42 of the cannula 34is mounted within a cannula carriage 44 that is initially positioneddirectly adjacent to the needle carriage 40. The needle carriage 40 ispivotally connected to an end of a linkage or crank arm 46, with anopposite end of the linkage 46 being associated with a torsion spring48. At the designated time (e.g., 3-5 minutes after the device 10 hasbeen activated), the controller causes a lever (not visible) to bereleased, which allows the spring 48 to recoil, in turn rotating thelinkage 46, which rotation causes the needle carriage 40 to move along alinear track 50 from a first position adjacent to the spring 48 (FIG. 3) to a second position spaced away from the spring 48. Movement of theneedle carriage 40 causes corresponding movement of the cannula carriage44 along the track 50, with the cannula 34 and the distal portion of theneedle 38 moving together in a direction away from the spring 48. Movingthe carriages 40 and 44 into the second position causes the sharp distalend of the needle 38 to advance out of the housing 12 via the cannulawindow 36 and pierce the skin. The cannula 34 is carried by or movesalong with the distal portion of the needle 38, such that the needle 38piercing the skin will also cause the distal end of the cannula 34 toenter into the skin.

Continued recoiling of the spring 48 causes further rotation of thelinkage 46, which has the effect of moving the needle carriage 40 backtoward the spring 48 (i.e., back toward its first position). Rather thanmoving along with the needle carriage 40, the cannula carriage 44 isheld in its second position (FIG. 3 ) by a lock or latch 52. As themovement of the needle carriage 40 is not restricted by the lock orlatch 52, the needle carriage 40 will return to its first position,while the cannula carriage 44 remains in its second position (with thefinal positions of both carriages 40 and 44 shown in FIG. 3 ).

Movement of the needle carriage 40 in a proximal direction away from thecannula carriage 44 causes the needle 38 to partially (but not fully)retract from the cannula 34. In the final condition shown in FIG. 3 ,the distal end of the needle 38 is positioned within the cannula 34(e.g., adjacent to a midsection or midpoint of the cannula 34), whilethe distal end of the cannula 34 remains positioned within the skin. Aproximal end of the needle 38 extends into fluid communication with thereservoir 14, such that the needle 38 provides a fluid path from thereservoir 14 to the cannula 34 when the carriages 40 and 44 are in thefinal condition illustrated in FIG. 3 . Due to the distal end of thecannula 34 remaining positioned within the skin, subsequent advancementof the drug out of the reservoir 14 (e.g., 27 hours after the device 10has been activated) will cause the drug to move into the needle 38 (viathe proximal end of the needle 38), through the needle 38 (to its distalend), and into the cannula 34. The drug is then delivered to the patient(e.g., over the course of a 45-minute session) via the distal end of thecannula 34 positioned within the skin.

As for the mechanism by which the drug is advanced out of the reservoir14, the device 10 includes a lever 54 mounted to a pivot point 56 (FIG.4 ). The lever 54 includes a first arm 58 configured and oriented tointeract with a first gear 60 and a second arm 62 configured andoriented to interact with a second gear 64. A tab 66 extends from anopposite end of the lever 54 and is configured and oriented toalternately move into and out of contact with two electrical contacts 68and 70 (electrically coupled to a printed circuit board, which is notshown) as the lever 54 pivots about the pivot point 56.

A first wire or filament 72 extends from the lever 54, around a firstpulley 74, and into association with a first electrical contact 76. Asecond wire or filament 78 extends from the lever 54 in the oppositedirection of the first wire 72, around a second pulley 80, and intoassociation with a second electrical contact 82. The wires 72 and 78(which are commonly referred to as “muscle wires”) are formed of a shapememory alloy (e.g., Nitinol), which causes them to heat up and contractwhen a current flows through them, while being allowed to stretch whenthe current is removed and the wire 72, 78 cools. Current is alternatelyapplied to the two wires 72 and 78, causing the one carrying a currentto heat up and contract while the other one is allowed to stretch. Thewire 72, 78 that contacts will pull on the lever 54, causing it to pivotabout the pivot point 56. Thus, alternately applying current to the twowires 72 and 78 will cause the wires 72 and 78 to alternately contactand stretch, which in turn causes the lever 54 to pivot back and forthabout the pivot point 56.

At the designated time (e.g., 27 hours after the device 10 has beenactivated), the controller provides commands that cause current to bealternately applied to the muscle wires 72 and 78, which causes thelever 54 to alternately pivot about the pivot point 56 in opposite firstand second directions. Pivotal movement of the lever 54 in the firstdirection will cause the first arm 58 of the lever 54 to engage androtate the first gear 60 an incremental amount, while pivotal movementof the lever 54 in the second direction will cause the second arm 62 ofthe lever 54 to engage and rotate the second gear 64 an incrementalamount (in the same direction in which the first gear 60 is rotated bythe first arm 58). Both gears 60 and 64 are associated with a commonshaft 84 (which is shown in FIG. 3 and may be formed with gears 60 and64 as a singled, molded piece), such that rotation of either gear 60, 64will cause the shaft 84 to rotate about its central axis. The shaft 84is mechanically coupled to the piston 28 within the reservoir 14, withrotation of the shaft 84 causing the piston 28 to move toward itsinitial position (e.g., by a threaded connection whereby rotation of theshaft 84 is translated into movement of the piston 28 along the lengthof the reservoir 14). As the piston 28 moves toward its initial position(from right to left in the orientation of FIG. 4 ), it will force thedrug out of the reservoir 14 via the proximal end of the needle 38. Asdescribed above, the drug will flow through the needle 38, into andthrough the cannula 34, and into the body of the patient.

After the drug has been delivered (e.g., over the course of a 45-minutesession), the controller alerts the patient via a visual cue from thestatus light 18 and/or an audible cue from the buzzer that drug deliveryis complete. Subsequently, the patient removes the device 10 from theirskin and discards the device 10.

While devices of the type described above have proven adequate, there isroom for improvement of them. For example, it is important to ensurethat the sterility of the system has been maintained, and that sterilityhas not been compromised due to, e.g., prior use. Thus, it would beadvantageous to provide medical infusion devices with systems thatprevent use of the infusion device if sterility has been compromised andalert the healthcare professional and/or patient of the non-sterilecondition.

SUMMARY

There are several aspects of the present subject matter which may beembodied separately or together in the devices and systems described andclaimed below. These aspects may be employed alone or in combinationwith other aspects of the subject matter described herein, and thedescription of these aspects together is not intended to preclude theuse of these aspects separately or the claiming of such aspectsseparately or in different combinations as set forth in the claimsappended hereto.

In a first aspect, an on-body drug delivery device is provided thatcomprises a housing and a cartridge removably attachable to the housing.The cartridge further comprises a fillable drug chamber, a pistonreceived in the drug chamber movable between a first, initial positionand a second position, an actuation device for moving the piston betweenthe first position and the second position, and at least one breakablesterility sensor circuit formed by attachment of the cartridge to thehousing, the circuit being closed when the cartridge is properlyattached to the housing and broken if the cartridge is not properlyattached to the housing or removed from the housing after being attachedthereto; and/or the circuit being broken if the piston is not in theinitial position when the cartridge is first attached to the housing.

In a second aspect, the piston further comprises one or more contactpoints that close the sterility sensor circuit when the piston is in theinitial position.

In a third aspect, the drug delivery device comprises a lock actuatedwhen the sterility circuit is broken to prevent operation of the drugdelivery device.

In a fourth aspect, the drug delivery device is further configured tocause a signal to be emitted if the sterility sensor circuit is broken.

In a fifth aspect, the signal is one or more of a tactile signal, anaudible signal or a visual signal that is emitted by the drug deliverydevice.

In a sixth aspect, the device is configured to cause the signal to beemitted by a separate device, such as a cell phone.

These and other aspects of the present subject matter are set forth inthe following detailed description of the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top perspective view of a drug delivery device according toconventional design.

FIG. 2 is a bottom perspective view of the drug delivery device of FIG.1 .

FIG. 3 is a top perspective view of the interior components of the drugdelivery device of FIG. 1 .

FIG. 4 is a bottom perspective view of the interior components of thedrug delivery device of FIG. 1 .

FIG. 5 is an exploded perspective view of a drug delivery deviceembodying the aspects of the present application.

FIG. 6 is a perspective view of the assembled drug delivery device ofFIG. 5 .

FIGS. 7 a and 7 b are perspective views of a drug delivery device inwhich a cartridge containing the drug reservoir includes breakablesterility sensor circuits formed between the side walls of the reservoirand a plunger contained within the reservoir, with the circuit shown asintact in FIG. 7 a and broken in FIG. 7 b due to movement of the plungerfrom the position shown in FIG. 7 a.

FIGS. 8 a and 8 b are perspective views of a drug delivery devicesimilar to the drug delivery device of FIGS. 7 a and 7 b.

FIGS. 9 a, 9 b, 9 c and 9 d schematically depict the reservoir of a drugdelivery device and an associated circuit and contact points for closingthe circuit, with FIG. 9 b showing the circuit being closed and FIGS. 9c and 9 d showing different conditions under which the circuit isbroken.

FIGS. 10 a, 10 b, 10 c, 10 d and 10 e are perspective views of a drugdelivery device in which breakable sterility sensor circuits are formedbetween the cartridge and the main body of the drug delivery device whenthe cartridge is attached to the main body, as shown in FIG. 10 a , andbroken when the cartridge is detached from the main body, as shown inFIG. 10 b.

FIGS. 11 a, 11 b and 11 c depict the reservoir of a drug delivery devicethat may be incorporated into the cartridge with breakable sterilitysensor circuits, with the sterility sensor circuits shown as intact inFIG. 11 a and broken in FIGS. 11 b and 11 c.

FIGS. 12 a, 12 b and 12 c depict a drug delivery device having amechanical locking system for preventing operation of the system if,upon attachment of the cartridge to the main body, a sterility sensorcircuit is broken.

DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

The embodiments disclosed herein are for the purpose of providing adescription of the present subject matter, and it is understood that thesubject matter may be embodied in various other forms and combinationsnot shown in detail. Therefore, specific designs and features disclosedherein are not to be interpreted as limiting the subject matter asdefined in the accompanying claims.

The methods and devices described herein may be used to deliver anysuitable fluid medication to a subject. In an exemplary embodiment, themethods and devices described herein are used to deliver pegfilgrastimto a subject, though other exemplary medications include (withoutlimitation) one or more of the following: adalimumab, rituximab,risankizumab, etanercept, trastuzumab, ado-trastuzumab emtansine,trastuzumab deruxtecan, bevacizumab, infliximab, pegfilgrastim,filgrastim, tocilizumab, golimumab, interferon beta-1a, ranibizumab,denosumab, pembrolizumab, nivolumab, aflibercept, eculizumab,ocrelizumab, pertuzumab, secukinumab, omalizumab, ustekinumab,vedolizumab, daratumumab, dupilumab, atezolizumab, natalizumab,bortezomib, ipilimumab, durvalumab, emicizumab, palivizumab, guselkumab,mepolizumab, panitumumab, ramucirumab, belimumab, abatacept,certolizumab pegol, ixekizumab, romiplostim, benralizumab, evolocumab,canakinumab, obinutuzumab, cetuximab, erenumab, blinatumomab,romosozumab, mirikizumab, inotuzumab, sacituzumab govitecan, enfortumabvedotin, brentuximab vedotin.

In keeping with the present disclosure, and with reference to FIGS. 5and 6 , the drug delivery/infusion device 10 has a modular constructionand comprises a main body 90 that houses many of the electro-mechanicalcomponents of the device and a removable cartridge 92 that is pre-filledand/or refillable with a drug. The removable cartridge 92 permitsre-filling and reuse of the infuser without having to remove it from thepatient after the initial attachment, and permits the device to be usedto deliver more than one type of drug. In cases where a drug must berefrigerated prior to use, a separable pre-filled cartridge 92 alsofacilitates storage of the drug apart from the main body 90, which maybe stored at room temperature, thus reducing the amount of refrigeratedstorage space required.

The cartridge further comprises a pre-filled drug chamber/reservoir 14,a piston/plunger 28, and a structure for pressurizing the drug heldwithin the chamber for delivery to the patient. As illustrated in FIG. 6, a spring 94 is employed for pressurizing the drug, although othermechanisms for pressurizing the drug may be employed without departingfrom the scope of the present disclosure. A seal 96 on the cartridge 92keeps the drug held within the chamber 14 sterile prior to attachment ofthe cartridge 92 to the main body 90, with the seal 96 being piercedupon attachment of the cartridge to the main body.

A mechanically- or electrically-actuated valve in the main body (notseen) serves to start, stop, and otherwise regulate flow of the drugfrom the infuser. The removable cartridge 92 is coupled to the main body90 by means of, e.g., a spring-loaded latch 98 that may be locked outduring infusion to prevent premature removal.

With a cartridge-based system such as that disclosed in FIGS. 5 and 6 ,it is important to ensure the sterility of the cartridge, as well as thecontents of the drug chamber prior to its attachment to the main body,and (in some cases) ensure against the attachment to a main body of acartridge that had been subject to prior use. To this end, one or moreconductive sterility sensor circuits may be formed at various locationswithin the cartridge, between the cartridge and the main body, or bothwithin the cartridge and between the cartridge and the main body. Thecircuit(s) would be broken, e.g., if the plunger/piston has been movedfrom an initial, unused position, if an adjacent component has beenmoved (e.g., to pierce a septum), and/or if the cartridge had beenpreviously installed and removed from an infusion device.

In a first example, and with reference to FIGS. 7 a,7 b and FIGS. 8 a, 8b , the plunger/piston 28 may be provided with contact points 100 thatclose a circuit 102 formed on or within the drug chamber/reservoir 14when the plunger/piston 28 is in its original position (FIG. 7 a , FIG.8 a ), and with the circuit being broken when the plunger/piston hasbeen moved from its initial position (FIG. 7 b , FIG. 8 b ).

In one embodiment, the circuit 102 is flexible and printed on orotherwise associated to a tearable substrate, optionally includingperforations. In one particular embodiment, the circuit 102 may bedefined by conductive ink printed on a paper or plastic label. Anexemplary circuit 102 is shown in FIG. 9 a.

As for the contact points 100 (which are also shown in FIG. 9 a ), inone embodiment, they are either directly soldered to or remotelyconnected to a printed circuit board (PCB) 103, which includes, or isconnected to, a controller of the main body. FIG. 9 a shows the contactpoints 100 separate from the circuit 102, while FIG. 9 b shows thecontact points 100 electrically coupled to the circuit 102, therebyclosing the circuit. The contact points may be differently configuredwithout departing from the scope of the present disclosure. For example,in one embodiment, the contact points are configured as slidingcontacts, such as leaf springs or spring-loaded pins, commonly called“pogo pins.”

When the circuit of the cartridge is closed or unbroken (as in FIG. 9 b), the controller of the main body will detect it. On the other hand, ifthe circuit is open (as in FIG. 9 a ) or broken (as in FIGS. 9 c and 9 d), the controller of the main body sees an open circuit. An open circuitoccurs if no sterile cartridge is detected (FIG. 9 a ), if the substratefor the circuit is partially torn (FIG. 9 c ), or the substrate for thecircuit is fully torn (FIG. 9 d), each of which looks the same to themain device, as if a cartridge is not installed at all. In oneembodiment, there may be a secondary mechanism for detecting thepresence of the cartridge, which could then trigger a check for thepresence or absence of circuit continuity, and yield an error message.

In another embodiment, and with reference to FIGS. 10 a-10 e , the mainbody 90 may be provided with contact points 104 of a PCB 105 that areconfigured to be electrically coupled to a circuit 106 formed on/in thecartridge 92 when a cartridge 92 is attached to the main body 90 (FIGS.10 a and 10 d ). The circuit 106 is configured to be open before thecartridge 92 is mounted to the main body 90 (FIGS. 10 b and 10 c ) orwhen a previously-used cartridge 92 is paired to the main body, whilebeing broken at the time that an installed cartridge 92 is detached fromthe main body 90 (FIG. 10 e ).

More particularly, in the embodiment of FIGS. 10 a-10 e , the main body90 is provided with snap-features 108 that engage complementarysnap-features 108 of the cartridge 92 when the main body 90 andcartridge 92 are brought together. As shown in FIGS. 10 c and 10 d , thecircuit 106 is incorporated into the cartridge 92 so as to be present atone or more locations that bring the circuit 106 into engagement withsnap-fit features 108 of the main body 90 when the cartridge 92 isassociated to the main body 90. This may include one or more portions ofthe circuit 106 being positioned at or adjacent to one or more of thesnap features 108 of the cartridge 92. When an unused cartridge 92 ispaired to the main body 90, one or more of the snap-fit features 108 ofthe main body 90 comes into contact with the circuit 106. Theillustrated snap-fit features 108 of the main body 90 are provided witha lip or extension 109 that passes by the circuit 106 duringinstallation of the cartridge 92 to the main body 90. This may beachieved, for example, by provided a flexible circuit 106 that istemporarily displaced by the extension 109 when the cartridge 92 ismounted to the main body 90, with the circuit 106 moving back toward itsinitial position once the extension 109 has passed by (FIG. 10 d ).

As can be seen in FIG. 10 d , the extension 109 effectively hooks behindor onto the circuit 106, such that subsequent disengagement of thecartridge 92 from the main body 90 will cause the extension 109 to pulland tear through the circuit 106, resulting in a permanently brokencircuit 106 (FIG. 10 e ). If the used cartridge 92 is later mated to thesame or a different main body 90 (e.g., if the cartridge 92 isrefilled), its circuit 106 will not be able to electrically couple withthe contact points 104 of the PCB 105. The controller of the main body90 (which is coupled to the PCB 105) will be able to determine that thecircuit 106 has not been electrically coupled to the PCB 105 and, inresponse, prevent reuse of the cartridge 92.

In a third example, and with reference to FIGS. 11 a, 11 b and 11 c , amain body includes contact points 110 and 112 that are electricallycoupled to a controller of a main body, such as via a PCB. A matingcartridge includes a pair of circuits 114 and 116 configured to beelectrically coupled to the contact points 110 and 112, respectively,upon association of the cartridge to the main body. The first circuit114 is connected to the drug reservoir 14 of the cartridge and to afirst needle holder 118 associated with the needle 38 of the cartridge,while the second circuit 116 is connected to the first needle holder 118and a second needle holder 120. In preparation for drug delivery, thefirst needle holder 118 is moved from its initial position (FIG. 11 a )toward the drug reservoir 14 to cause the proximal end of the needle 38to pierce a septum 122 that closes drug reservoir 14 (FIG. 11 b ). Thefirst circuit 114 is associated to the drug reservoir 14 and the firstneedle holder 118 such that this movement of the first needle holder 118toward the drug reservoir 14 causes the circuit 114 to become pinchedbetween the first needle holder 118 and the drug reservoir 14, whichcauses the circuit 114 to break, as shown in FIG. 11 b . Subsequently,the second needle holder 120 is moved away from the first needle holder118 to cause the distal end of the needle 38 to move toward the skin ofthe patient (FIG. 11 c ). The second circuit 116 is associated to thefirst needle holder 118 and the second needle holder 120 such that thismovement of the second needle holder 120 away from the first needleholder 118 causes the circuit 116 to stretch and break, as shown in FIG.11 c.

While FIGS. 11 a-11 c are shown with two circuits that are broken inpreparation for drug delivery, it should be understood that breakingeither may be sufficient to render the cartridge unusable after drugdelivery has been completed. It should also, thus, be understood that,in other embodiments, it may be sufficient for only one circuit to beprovided and broken to signal that a cartridge has been used. As can beappreciated, circuits/contact points may be advantageously associatedwith other structures in the cartridge/main body that move relative toone another upon use of the cartridge, such that the circuit is brokenupon movement from an initial position.

In another aspect of the present disclosure, the infusion device 10 maybe provided with a locking system that prevents operation of/deactivatesthe device if, when a cartridge is attached to the main body, anycircuits, such as those described above, are broken. The device wouldremain inoperable/deactivated until a cartridge with intact circuits isproperly attached to the main body. The locking system may beelectronic, so that, e.g., upon detection of the attachment to the mainbody of a cartridge with a broken circuit, the device would not beginany infusion steps. Alternatively, the broken circuits may simply beindicators of the loss of sterility that get checked for continuity bythe device, in which case the device would be capable of all functions.Under such circumstances, the controller would assess the state of thecircuit(s), and raise a warning and/or move to an error state uponfinding a lack of continuity.

Alternatively, the locking system could be in the form of a mechanicallock that, when actuated, blocks movement of a component of the devicethat is moved during operation. By way of example, and with reference toFIG. 12 a , the infusion device 10 is provided with a push button 124that extends through an opening in the main body 90 and is used toactuate the needle 38. As seen in FIGS. 12 b and 12 c , the push button124 is formed as part of an elongated shaft 126 that extends into theinterior of the main body 90. When the button 124 is pushed, the shaft126 will move inwardly so that its end will engage a mechanism (notshown) for actuating the needle so as to cause the needle to engage thepatient. A latch 128 is pivotally mounted on the interior of the housing90 to which a memory/muscle wire 130 is secured. If the sterility sensorcircuits are intact, current is delivered to the memory wire 130 tocontract the wire to maintain the latch 128 in a position in which itwill not interfere with movement of the push button 124 (FIG. 12 b ). Onthe other hand, if a sterility sensor circuit is broken, current willnot be delivered to the memory wire 130, and the wire will relax, thuspivoting the latch 128 into a position where it blocks movement of thepush button 124 (FIG. 12 c ).

Upon triggering of the locking system, an alert may also be provided tothe healthcare provider and/or the patient by, e.g., the infusion deviceproviding a tactile, visual and/or audible signal, or by providingnotification on, e.g., a cell phone through an app connecting theinfusion device to the cell phone.

It will be understood that the embodiments and examples described aboveare illustrative of some of the applications of the principles of thepresent subject matter. Numerous modifications may be made by thoseskilled in the art without departing from the spirit and scope of theclaimed subject matter, including those combinations of features thatare individually disclosed or claimed herein. For these reasons, thescope hereof is not limited to the above description but is as set forthin the following claims, and it is understood that claims may bedirected to the features hereof, including as combinations of featuresthat are individually disclosed or claimed herein.

The invention claimed is:
 1. An on-body drug delivery device comprising:a main body including a fluid flow path and a housing defining a bodyinterface; an adhesive pad associated with a lower surface of thehousing and configured to be removably attached to a human body surface;a cartridge removably attachable to the main body and including afillable drug chamber having an outlet and a seal configured to beopened upon the cartridge being attached to the main body so as to placethe fluid flow path into fluid communication with the outlet; a needlefluidically connected to the fluid flow path; and a controllerconfigured to execute a drug delivery routine, wherein the cartridgefurther includes a cartridge housing defining a cartridge interfaceconfigured to be associated to the body interface upon the cartridgebeing attached to the main body, a piston received in the drug chambermovable from a first, initial position to a second position to convey adrug from the drug chamber to the needle during said drug deliveryroutine, an actuation device for moving the piston from the firstposition to the second position, and at least one breakable sterilitysensor circuit formed by attachment of the cartridge to the main body,the at least one breakable sterility circuit being closed when thecartridge is properly attached to the main body, open when the cartridgeis not properly attached to the main body, and broken when the cartridgeis removed from the main body after being properly attached theretoand/or when the piston is not in the initial position when the cartridgeis first attached to the main body.
 2. The on-body drug delivery deviceof claim 1 wherein the piston further comprises one or more contactpoints that close the at least one breakable sterility sensor circuitwhen the piston is in the initial position.
 3. The on-body drug deliverydevice of claim 2 wherein the drug delivery device is further configuredto cause a signal to be emitted when the at least one breakablesterility sensor circuit is broken.
 4. The on-body drug delivery deviceof claim 3 wherein the signal is one or more of a tactile signal, anaudible signal or a visual signal that is emitted by the drug deliverydevice.
 5. The on-body drug delivery device of claim 2 furthercomprising a lock actuated when the at least one breakable sterilitysensor circuit is broken to prevent operation of the drug deliverydevice.
 6. The on-body drug delivery device of claim 1 furthercomprising a lock actuated when the at least one breakable sterilitysensor circuit is broken to prevent operation of the drug deliverydevice.
 7. The on-body drug delivery device of claim 6 wherein the drugdelivery device is further configured to cause a signal to be emittedwhen the at least one breakable sterility sensor circuit is broken. 8.The on-body drug delivery device of claim 1 wherein the drug deliverydevice is further configured to cause a signal to be emitted when the atleast one breakable sterility sensor circuit is broken.
 9. The on-bodydrug delivery device of claim 8 wherein the signal is one or more of atactile signal, an audible signal or a visual signal that is emitted bythe drug delivery device.
 10. The on-body drug delivery device of claim8 wherein the device is configured to cause the signal to be emitted bya separate device.
 11. The on-body drug delivery device of claim 10wherein the separate device is a cell phone.
 12. The on-body drugdelivery device of claim 1 further comprising a spring-loaded latch forsecuring the cartridge to the housing.
 13. The on-body drug deliverydevice of claim 12 wherein the spring-loaded latch is locked-out duringoperation of the device.
 14. The on-body drug delivery device of claim 1further comprising snap-fit structures for securing the cartridge to themain body.
 15. The on-body drug delivery device of claim 14 wherein theat least one breakable sterility sensor circuit and/or contact pointsare associated with the snap-fit structures.
 16. The on-body drugdelivery device of claim 1 further comprising the needle mounted to amovable needle holder and in which the at least one breakable sterilitysensor circuit and/or a contact point is associated with the needleholder.
 17. The on-body drug delivery device of claim 1 furthercomprising first and second breakable sterility sensor circuits, theneedle mounted to first and second needle holders, the first needleholder for moving the needle so as to pierce a septum interior of thedrug chamber and the second needle holder for moving the needle toengage with a patient, the first breakable sterility sensor circuitassociated with the first needle holder and the second breakablesterility sensor circuit associated with the second needle holder. 18.The on-body drug delivery device of claim 1 further comprising a pushbutton for actuating the needle, the push button extending through anopening in the housing, and a latch pivotally mounted on an interior ofthe housing and selectively engageable with the button to permit orprevent actuation of the needle.
 19. The on-body drug delivery device ofclaim 18 further comprising a memory wire associated with the latch andconnected to a source of current for moving the latch between a firstposition to permit movement of the push button and a second position toprevent movement of the push button.
 20. The on-body drug deliverydevice of claim 1 wherein the fillable drug chamber containspegfilgrastim.
 21. The on-body drug delivery device of claim 1 whereinthe device is configured to communicate wirelessly with a separatedevice.
 22. The on-body drug delivery device of claim 1 wherein thedevice is configured to communicate wirelessly with a separate device ofa patient.
 23. The on-body drug delivery device of claim 1 wherein thedevice is configured to communicate wirelessly with a separate device ofa healthcare provider.
 24. An on-body drug delivery device comprising: amain body including a fluid flow path and a housing defining a bodyinterface; an adhesive pad associated with a lower surface of thehousing and configured to be removably attached to a human body surface;a cartridge removably attachable to the main body and including afillable drug chamber having an outlet and a seal configured to beopened by attachment of the cartridge to the main body so as to placethe fluid flow path into fluid communication with the outlet; a needlefluidically connected to the fluid flow path; and a controllerconfigured to execute a drug delivery routine, wherein the cartridgefurther includes a cartridge housing defining a cartridge interfaceconfigured to be associated to the body interface upon the cartridgebeing attached to the main body, a piston received in the drug chambermovable from a first, initial position to a second position to convey adrug from the drug chamber to the needle during said drug deliveryroutine, an actuation device for moving the piston from the firstposition to the second position, and at least one breakable sterilitysensor circuit formed by attachment of the cartridge to the main body,the at least one breakable sterility circuit being at least onebreakable sterility sensor circuit formed by attachment of the cartridgeto the main body, the at least one breakable sterility circuit beingclosed when the cartridge is properly attached to the main body, openwhen the cartridge is not properly attached to the main body, and brokenwhen the cartridge is removed from the main body after being properlyattached thereto and/or when the piston is not in the initial positionwhen the cartridge is first attached to the main body.
 25. An on-bodydrug delivery device comprising: a main body including a fluid flow pathand a housing defining a body interface; an adhesive pad associated witha lower surface of the housing and configured to be removably attachedto a human body surface; a cartridge removably attachable to the mainbody and including a fillable drug chamber having an outlet and a sealconfigured to be automatically opened upon the cartridge being attachedto the main body so as to place the fluid flow path into fluidcommunication with the outlet; a needle fluidically connected to thefluid flow path; and a controller configured to execute a drug deliveryroutine, wherein the cartridge further includes a cartridge housingdefining a cartridge interface configured to be associated to the bodyinterface upon the cartridge being attached to the main body, a pistonreceived in the drug chamber movable from a first, initial position to asecond position to convey a drug from the drug chamber to the needleduring said drug delivery routine, an actuation device for moving thepiston from the first position to the second position, and at least onebreakable sterility sensor circuit formed by attachment of the cartridgeto the main body, the at least one breakable sterility circuit beingclosed when the cartridge is properly attached to the main body, openwhen the cartridge is not properly attached to the main body, and brokenwhen the cartridge is removed from the main body after being properlyattached thereto and/or when the piston is not in the initial positionwhen the cartridge is first attached to the main body.